Clinical Trial Summary

The current study aimed to develop and assess an easy-to-use, highly accessible mobile and
web-based application intervention to reduce sedentary behavior and increase physical
activity in the hope of reducing the side effects of treatment and improving quality of life
for the 13,000 or more prostate cancer survivors who are prescribed ADT each year in Canada.
The study was conducted in two phases, where Phase one was focused on finding out about the
attitudes and perceptions of sedentary behavior and the use of mobile applications among
prostate cancer survivors using semi-structured interviews. Together with professional
experts and a group of men who were diagnosed with prostate cancer, we developed RiseForTx -
an application that is used on a smartphone or tablet to reduce time spent in, and to change
patterns of, sedentary behaviour each day (Phase two). Part of the intervention was also
focused on increasing daily steps to improve physical activity. We tested the intervention to
examine (i) how the application works, (ii) if prostate cancer survivors like it and use it;
and (iii) if sedentary behaviour and physical activity can reduce the impact of the side
effects for treatment and improve quality of life among men on ADT.

Clinical Trial Description

In the first 10 days following recruitment, participants met with the research coordinator
and were provided with an accelerometer (GT3X) and completed self-report baseline measures.
Provided along with the RiseTx application is the Jawbone, which is a wrist-worn device that
can assess activity patterns throughout the day and provide sensory alerts to stand after
prolonged sitting (i.e., ≥30 minutes of sedentary time). The intervention consisted of five
phases following initial data collection, including a baseline phase (weeks 1-2) where
participants self-monitored their typical leisure time PA (i.e., step counts) and were asked
to 'sync' their Jawbone with the RiseTx application to view their daily progress and steps.
This daily self-monitoring process continued over the remaining intervention period. Based on
a previously tested ramped step count approach that focuses on increasing walking by an extra
1000 daily steps over a set period, participants attempted to increase daily steps by 1000
over the average of their baseline week. Phases I-III involved progressive release of
self-regulatory strategies (e.g., action planning) on the application and targeted changes in
both sitting time (and breaks in sitting time) and step counts. Phase I (weeks 3-4) focused
on increasing low intensity, incidental movement, through the use of an alerting device, and
the Jawbone (reminder to break SED). At this time, an additional +1000 daily step increment
was set above baseline. Phase II (weeks 5-6) targeted shorter planned PA (of up to 10 mins)
by having participants form action plans on the application for both reducing SED and
increasing PA. An additional +1000 daily step increment was set above Phase I. Phase III
(weeks 7-8) focused on promoting longer, moderate intensity PA (>10 min), where participants
used the application to form coping plans for barriers to reducing sitting time or engaging
in PA. An additional +1000 daily step increment was set above Phase II step target. A 4-week
consolidation phase (Phase IV and V; weeks 9-12) followed, where participants received weekly
reminders that encouraged them to continue to use the RiseTx application to practice
combining the different self-regulatory strategies learned in Phases I-III. Following the
intervention, there was a 12-week maintenance period (weeks 13-24) where participants no
longer received weekly self-regulatory practice reminders, yet still had access to the
application.
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Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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